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Km80.5

Associate Director, Chemistry, Manufacturing & Controls (CMC)

Cerus Corporation

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Location: Concord, CA Posted Date: 4/19/2013 Position Type: Full time Job Code: ADCMC Required Education: High school or equivalent Areas of Expertise Desired: Chemistry
Manufacturing/Production

Description

Summary & Scope of Position:  
Technical lead for Chemistry, Manufacturing, and Controls (CMC) activities for INTERCEPT Blood Systems for Platelets, Plasma, and Red Blood Cells.    Scope includes support for new product development, product improvements, cost savings, and commercial manufacturing.  The INTERCEPT Blood Systems are regulated as Class III drug/device combination products.  

Primary Responsibilities:  
•   Provide technical leadership and oversight for all development and manufacturing activities related to psoralen- and acridine-based small molecules, glutathione, and buffered formulations.  This is a high-level individual contributor role which requires extensive interaction with external contractors and other groups within Cerus.    
•   Participate in the selection, contracting, and day-to-day management of external suppliers involved in the development and manufacturing of Cerus products.  
•   Member of CMC and disposable device subteams; participate in cross-functional product development teams as appropriate.
•   Areas of responsibilities for drug substance and drug product include but are not limited to:  process and analytical method development and validation; formulation development; container/closure selection; and stability studies.   Responsible for the review and approval of protocols and reports prepared by external contractors.
•   Ensure compliance with applicable regulatory requirements and guidance for the development and manufacturing of drug substances and drug products (including ICH, EP, USP).      
•   Participate in defining the development and manufacturing plan for clinical and commercial products.
•   Identify issues and ensure that appropriate actions are taken to achieve goals, timelines, and budgets.  
•   Interact extensively with peers in R&D, Manufacturing, Regulatory, and Quality.   Serve as technical resource on chemistry and analytical issues related to reagents and disposable devices.  
•   Author CMC sections of regulatory submission documents.

Requirements

Qualifications/Requirements/Skills:
•   Masters or Ph.D. in Chemistry, Chemical Engineering, or BioMedical Engineering with a minimum of 7 years experience in drug or device development.
•   Experience working with external contractors involved in development and manufacturing is a must.
•   Expertise with ICH guidelines and EP/USP requirements and methods is a must.
•   Prior experience in GMP environment is a must
•   Experience with both aseptic processes and terminal sterilization processes is preferred
•   Demonstrated technical capabilities related to drug development and manufacturing
•   Effective communication and interpersonal skills.
•   Ability to work in a fast paced environment and effectively manage multiple competing tasks and demands.
•   Ability to work independently, take initiative and complete tasks to deadlines.  
•   Flexible; ability to adapt to changing priorities.
•   Strong technical and problem solving skills.
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